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Last Updated: April 22, 2024

Risperidone - Generic Drug Details


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What are the generic sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in six branded drugs marketed by Shandong Luye, Indivior, Janssen Pharms, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Tris Pharma Inc, Wockhardt, Teva, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Jubilant Generics, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Heritage Pharma Avet, Jubilant Cadista, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in fifty-two NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has one hundred and forty-seven patent family members in thirty-nine countries.

There are thirty drug master file entries for risperidone. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for risperidone

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Drug Sales Revenue Trends for risperidone

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Recent Clinical Trials for risperidone

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SponsorPhase
All India Institute of Medical Sciences, BhubaneswarN/A
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
University of New MexicoPhase 4

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1MG/MLSOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone
Medical Subject Heading (MeSH) Categories for risperidone
Anatomical Therapeutic Chemical (ATC) Classes for risperidone
Paragraph IV (Patent) Challenges for RISPERIDONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RISPERDAL Orally Disintegrating Tablets risperidone 0.25 mg 021444 1 2005-04-11
RISPERDAL Orally Disintegrating Tablets risperidone 3 mg and 4 mg 021444 1 2005-03-23

US Patents and Regulatory Information for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms RISPERIDONE risperidone TABLET;ORAL 079088-006 Oct 30, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
West Ward Pharms RISPERIDONE risperidone TABLET;ORAL 078740-001 May 29, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Celltrion RISPERIDONE risperidone TABLET;ORAL 078871-001 Oct 9, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva UZEDY risperidone SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 213586-002 Apr 28, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Heritage Pharma Avet RISPERIDONE risperidone TABLET;ORAL 077769-002 Oct 16, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva UZEDY risperidone SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 213586-007 Apr 28, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-003 Dec 29, 1993 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-005 Dec 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-004 Dec 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for risperidone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A. Okedi risperidone EMEA/H/C/005406
Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.
Authorised no no no 2022-02-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for risperidone

Country Patent Number Title Estimated Expiration
South Korea 101197540 ⤷  Try a Trial
Hungary E046004 ⤷  Try a Trial
Cyprus 1119829 ⤷  Try a Trial
Japan 2016128411 小分子薬の持続放出製剤 (SUSTAINED RELEASE PREPARATION OF SMALL MOLECULE DRUG) ⤷  Try a Trial
Hungary E032310 ⤷  Try a Trial
Taiwan 200803920 Sustained release small molecule drug formulation ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for risperidone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196132 94C0008 Belgium ⤷  Try a Trial PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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